Corresponding Author: Axel R. Franz, MD, Center for Pediatric Clinical Studies, Department of Neonatology, University Children’s Hospital Tübingen, Calwerstrasse 7, 72076 Tübingen, Germany (axel.franz@med.uni-tuebingen.de).
Accepted for Publication: June 2, 2020.
Correction: This article was corrected on July 12, 2022, to include the nonauthor collaborator names in a supplement.
Author Contributions: Dr Franz had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Franz, Bassler, Rüdiger, Thome, Maier, Krägeloh-Mann, Kron, Roll, Poets.
Acquisition, analysis, or interpretation of data: Franz, Engel, Bassler, Thome, Maier, Krägeloh-Mann, Kron, Essers, Bührer, Rellensmann, Rossi, Bittrich, Roll, Höhn, Ehrhardt, Avenarius, Körner, Stein, Buxmann, Vochem, Poets.
Drafting of the manuscript: Franz.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Franz, Kron.
Obtained funding: Franz, Bassler.
Administrative, technical, or material support: Franz, Rüdiger, Maier, Bührer, Roll, Höhn, Ehrhardt, Avenarius, Buxmann, Vochem.
Supervision: Franz, Engel, Bassler, Rüdiger, Kron, Bittrich, Buxmann, Poets.
Conflict of Interest Disclosures: Dr Kron reported receipt of personal fees from AbbVie Inc. Dr Poets reported receipt of speaker honoraria from Masimo Inc and Sentec AG. No other disclosures were reported.
Funding/Support: The trial was funded by German Research Foundation (Deutsche Forschungsgemeinschaft) grants Fr-1455/6-1 and Fr-1455/6-2.
Role of the Funder/Sponsor: The German Research Foundation had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. The funding organization did not have the right to veto publication or to control the decision regarding to which journal the manuscript was submitted.
Group Information: ETTNO Investigators: nonauthor contributions to data collection and analysis: Christian A. Maiwald, MD, Gabriele von Oldershausen, Iris Bergmann, MSc, Michael Raubuch, PhD, Wolfgang Buchenau, MD, Birgit Schuler, MA, Center for Pediatric Clinical Studies, University Children’s Hospital Tübingen, Tübingen, Germany (data management, monitoring, and study coordination); Silvia Sander, Institute for Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany (biometry/analysis programmer); Hans-Ulrich Bucher, MD, University Hospital Zurich, Zurich, Switzerland, Heike Rabe, MD, University of Brighton, Brighton, England, Josef Högel, PhD, University of Ulm, Ulm, Germany (data monitoring committee); Tamam Bakchoul, MD, Sigrid Enkel, MD, Transfusion Medicine, University Hospital Tübingen, Tübingen, Germany (blood bank advisory board). Recruiting hospitals and local investigators contributing to patient recruitment and data collection: Germany: Reinhard Hopfner, MD, Manuel B. Schmid, MD, Steffen Ruess, MD, Helmut D. Hummler, MD, Maria Zernickel (University Hospital Ulm, Ulm); Christof Dame, MD, Christoph Czernik, MD, Lars Garten, MD, Florian Guthmann, MD, Dieter Hüseman, MD, Elisabeth Walch, MD, Jessica Blank (Charité Universitätsmedizin Berlin, Berlin); Esther Rieger-Fackeldey, MD, Claudius Werner, MD, Katja Masjosthusmann, MD, Julia Sandkötter, MD, Isabell Hörnig-Franz, MD (University Hospital Münster, Münster); Thomas Kühn, MD, Michael Emeis, MD, Mikosch Wilke, MD, Henriette Schönemann, MD (Klinikum Neukölln, Berlin); Kathrin Roefke, MD (Helios Klinikum Erfurt, Erfurt); Wolfgang Pielemeier, MD, Patrizia Kutz, MD, Laura Stüwe-Kunz, MD (Vestische Kinder-und Jugendklinik Datteln, Universität Witten/Herdecke, Datteln); Klaus Lohmeier, MD, Renate Richter-Werkle, MD (University Hospital Düsseldorf, Düsseldorf); Lars Klein, MD, Dirk Faas, MD (Department of General Pediatrics and Neonatology, Justus-Liebig-University Giessen, Giessen); Rangmar Goelz, MD, Jörg Arand, MD, Ingo Müller-Hansen, MD, Karen B. Kreutzer, MD, Cornelia Wiechers, MD, Christoph E. Schwarz, MD, Irene Steiner-Wilke (University Children’s Hospital Tübingen, Tübingen); Ralf Böttger, MD, Claudia Jungbluth-Strauch, Janine Heindorf (University Hospital Magdeburg, Magdeburg); Christoph Härtel, MD (Campus Lübeck, University Hospital Schleswig-Holstein, Lübeck); Levente Bejo, MD (Klinikum Links der Weser, Bremen); Britta M. Hüning, MD (Department of Paediatrics I, University Duisburg-Essen, Essen); Rolf Schlößer, MD, Doris Fischer, MD, Antje Allendorf, MD (University Hospital Frankfurt, Frankfurt); Michael Zemlin, MD, Pia Göbert, MD, Susanne Kampmann, MD, Silke Thomsen, Mirjam Wege, Franziska Heinz, Evelyn Grandmontagne (University Hospital Marburg, Marburg); Martin Wagner, MD, Ulrich Pohlmann, MD, Patrick Neuberger, MD, Thomas Strahleck, MD, Marlene Westmeier, MD, Zoubida El Hafid, MD, Iris Kallenberg, MD, Aurelia Giordano (Klinikum Stuttgart, Olgahospital, Stuttgart); Annett Bläser, MD, Corinna Gebauer, MD (University Hospital Leipzig, Leipzig); Jürgen Seidenberg, MD, Jeannette Dege, MD, Birgitt Moed, MD (Universitätsklinik für Kinder-und Jugendmedizin, Klinikum Oldenburg AöR, Oldenburg); Orsolya Genzel-Boroviczény, MD, Stefanie Artmann, MD (University Hospital Munich, Munich); Rainer Burghard, MD, Mechthild Hubert, MD, Susanne Lüttchens, MD (DRK-Kinderklinik Siegen, Siegen); Bettina Bohnhorst, MD, Corinna Peter, MD, Christoph Jacobi, MD (Medizinische Hochschule Hannover, Hannover); Barbara Seipolt, MD, Violeta Cerda Ojinaga, MD, Arite Koch, Beate Walter (University Hospital Carl Gustav Carus, Dresden); Hugo Segerer, MD, Annette Keller-Wackerbauer, MD, Jochen Kittel, MD (Department of Neonatology, University Children’s Hospital Regensburg, KUNO, Regensburg); Norbert Teig, MD, Susanne Wiegand, MD, Almut Weitkämper, MD (St Elisabeth-Hospital, Universitätskinderklinik Bochum, Bochum); Dominique Singer, MD, Sarah Kabisch, MD, Monika Wolf, MD (University Medical Center Hamburg-Eppendorf, Hamburg); Mark Schoberer, MD, Thorsten Orlikowsky, MD, Sonja Trepels-Kottek, MD, Victoria Rotering, MD, Catherine Ley (University Hospital Aachen, Aachen); Gernot Buheitel, MD, Wilfried Schenk, MD, Anne C. Garbe, MD (Klinikum Augsburg, Augsburg); Matthias Heckmann, MD, Hagen Bahlmann, MD (Universitätsmedizin Greifswald, Greifswald); Stefan Schäfer, MD, Holger Schiffmann, MD, Bettina Behring, MD, Tanja Bauer, MD (Klinikum Nürnberg Süd, Nürnberg); Hans-Georg Topf, MD, Patrick Morhart, MD, Regina Trollmann, MD, Michael Schroth, MD (University Hospital Erlangen, Erlangen); Angela Kribs, MD, Sandra Zawatzki, MD (University Hospital Cologne, Cologne); Axel von der Wense, MD, Peter Gudowius, MD (Altonaer Kinderkrankenhaus, Hamburg). Other countries: Jes Reinholdt Petersen, MD, Gitte Veiergang, MD, Gorm Greisen, MD (Rigshospitalet Copenhagen, Copenhagen, Denmark); Ulla Christensen, MD, Tine Brink Henriksen, MD (Aarhus Universitetshospital, Aarhus, Denmark); Tuuli Metsvaht, MD (Tartu University Hospital, Tartu, Estonia); Renáta Polácková, MD (The Medical University Ostrava, Ostrava, Czech Republic).
Data Sharing Statement: See Supplement 3.
Nonauthor Collaborators: The ETTNO Investigators are listed in Supplement 4.
Additional Contributions: The ETTNO Investigators thank the children and their families for their participation and support. We are grateful for the support of the staff at all participating hospitals and we acknowledge the contributions of Gitte Veiergang, MD, investigator at the Rigshospitalet, Copenhagen, and Joachim Riethmüller, MD, cochair of the Center for Pediatric Clinical Studies and responsible for monitoring in this trial, University Hospital Tübingen, who died during the course of this study. (Neither received compensation for their contribution.)
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